Prospecto: information for the patient

Ofev 100mg soft capsules

nintedanib

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this prospect. See section4.

1.What Ofev is and for what it is used

2.What you need to know before starting to take Ofev

3.How to take Ofev

4.Possible adverse effects

5.Storage of Ofev

6. Contents of the package and additional information

Ofev contains the active ingredient nintedanib, a medication that belongs to the class of tyrosine kinase inhibitors,and is used to treat the following diseases:

Idiopathic Pulmonary Fibrosis (IPF) in adults

IPF is a disease that causes thickening, hardening, and scarring of the tissue in your lungs over time. As a result, scarring reduces the ability to transfer oxygen from the lungs to the bloodstream, making it difficult to breathe deeply. Ofev helps to reduce the appearance of further scarring and hardening of the lungs.

Other chronic progressive fibrosing interstitial lung diseases (cP-ILDs) in adults

In addition to IPF, there are other diseases in which the tissue in your lungs presents thickening, hardening, and scarring over time (pulmonary fibrosis) and continues to worsen (progressive phenotype). Examples of these diseases include hypersensitivity pneumonitis, autoimmune interstitial lung diseases (such as interstitial lung disease associated with rheumatoid arthritis), idiopathic interstitial pneumonia, idiopathic interstitial pneumonia not classifiable, and other interstitial lung diseases. Ofev helps to reduce the appearance of further scarring and hardening of the lungs.

Chronic progressive fibrosing interstitial lung diseases (cP-ILDs) in children and adolescents aged 6 to 17 years

Fibrosis of the lungs can occur in patients with childhood interstitial lung disease. In this case, the lung tissue of children and adolescents presents thickening, hardening, and scarring over time.Ofev helps to reduce the appearance of further scarring and hardening of the lungs.

Interstitial lung disease associated with systemic sclerosis (ILD-SSc)in adults, adolescents, and children aged 6 years and older

Systemic sclerosis (SSc), also known as scleroderma (and systemic sclerosis in children and adolescents), is a rare chronic autoimmune disease that affects the connective tissue in many parts of the body. SSc causes fibrosis (scarring and hardening) of the skin and other internal organs, such as the lungs. When the lungs are affected by fibrosis, it is called interstitial lung disease (ILD) and, therefore, the disease is called ILD-SSc. Fibrosis in the lungs reduces the ability to transfer oxygen to the bloodstream and reduces the ability to breathe. Ofev helps to reduce the appearance of further scarring and hardening of the lungs.

Do not take Ofev

• if you are pregnant,
• if you are allergic to nintedanib, peanuts, soy, or any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ofev

• if you have or have had liver problems,
• if you have or have had kidney problems, or if you have been found to have an increase in the amount of protein in your urine,
• if you have or have had bleeding problems,
• if you are taking medications to thin your blood (such as warfarin, phenprocoumon, or heparin) to prevent blood clots,
• if you are taking pirfenidone, as this may increase the risk of diarrhea, nausea, vomiting, and liver problems,
• if you have or have had heart problems (such as a heart attack),
• if you have recently undergone surgery. Nintedanib may affect the way wounds heal. Therefore, treatment with Ofev will usually be interrupted for a time if you undergo surgery. Your doctor will decide when to resume treatment with this medication.
• if you have high blood pressure,
• if you have abnormally high blood pressure in the blood vessels of the lungs (pulmonary hypertension),
• if you have or have had an aneurysm (enlargement and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.

Based on this information, your doctor may perform some blood tests, for example, to check your liver function. Your doctor will discuss the results of these tests with you to decide if you can take Ofev.

Inform your doctor immediately while taking this medication

• if you have diarrhea. It is essential to treat diarrhea early (see section4, “Possible side effects”);
• if you have vomiting or nausea;
• if you have unexplained symptoms such as yellowing of the skin or the white of the eyes (jaundice), dark or tea-colored urine, abdominal pain on the right upper side, bleeding, or easy bruising, or if you feel tired. These may be symptoms of severe liver problems;
• if you have acute abdominal pain, fever, chills, dizziness, vomiting, or abdominal rigidity or swelling, as these may be symptoms of a hole in the wall of the intestines (“gastrointestinal perforation”). Inform your doctor if you have had peptic ulcers or diverticular disease in the past or if you are being treated with anti-inflammatory medications (AINE) (used to relieve pain and swelling) or steroids (used against inflammation and allergies) at the same time, as this may increase this risk;
• if you have a combination of intense or colicky abdominal pain, bloody stools, or diarrhea, as these may be symptoms of intestinal inflammation due to inadequate blood supply;
• if you have pain, swelling, redness, or heat in a limb, as these may be symptoms of a blood clot in one of your veins (a type of blood vessel);
• if you have chest pressure or pain, usually on the left side of the body, neck, jaw, shoulder, or arm, rapid heartbeat, difficulty breathing, nausea, or vomiting, as these may be symptoms of a heart attack;
• if you have significant bleeding;
• if you experience bruising, bleeding, fever, fatigue, and confusion, as these may be signs of a blood vessel injury known as microangiopathic thrombosis (MAT);
• if you experience symptoms such as headache, changes in vision, confusion, seizures, or other neurological changes such as weakness in an arm or leg, with or without high blood pressure, which may be symptoms of a brain disorder called posterior reversible encephalopathy syndrome (PRES).

Children and adolescents

Children under 6 years old should not take Ofev.

Your doctor may perform dental check-ups at least every 6 months until the development of your teeth is complete and monitor your growth once a year (bone imaging study) while taking this medication.

Other medications and Ofev

Inform your doctor or pharmacist if you are taking, have taken recentlyormay have to take any other medication, including herbal remedies and over-the-counter medications.

Ofev may interact with other medications. The following medications may

increase the levels of nintedanib in the blood and, therefore, increase the risk of adverse effects (see section4, “Possible side effects”):

-a medication used to treat fungal infections (ketoconazole)

-a medication used to treat bacterial infections (erythromycin)

-a medication that affects your immune system (ciclosporin)

The following medications are examples that may decrease the levels of nintedanib in the blood and, therefore, reduce the effectiveness of Ofev:

-an antibiotic used to treat tuberculosis (rifampicin)

-medications used to treat seizures (carbamazepine, phenytoin)

-a herbal remedy used to treat depression (St. John's Wort)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not take this medication during pregnancy, as it may harm the fetus and cause congenital defects.

You should have a pregnancy test to ensure you are not pregnant before starting treatment with Ofev. Consult your doctor.

Contraception

• Women who may become pregnant should use a highly effective contraceptive method to avoid pregnancywhen starting to take Ofev,while taking Ofev, and for at least 3 months afterstoppingthe treatment.
• Consult your doctor about the most suitable contraceptive methods for you.
• Vomiting and/or diarrhea, or other gastrointestinal disorders, may affect the absorption of oral contraceptives, such as birth control pills, and may reduce their effectiveness. Therefore, if you experience any of these situations, consult your doctor to evaluate an alternative contraceptive method that is more suitable for you.
• Inform your doctor or pharmacist immediately if you become pregnantor think you may be pregnantwhile taking Ofev.

Breastfeeding

Do not breastfeed your baby while taking Ofev, as it may harm the infant.

Driving and operating machinery

Ofev has little effect on the ability to drive and use machines. Do not drive or use machines if you feel dizzy.

Ofev contains soy lecithin

If you are allergic to soy or peanuts, do not take this medication (see section2, “Do not take Ofev”).

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Take the capsulestwice a daywith a 12-hour difference and approximately at the same time of day; for example, one capsule in the morning and one capsule at night. This way, you will ensure that a constant level of nintedanib is maintained in your blood. Swallow the capsules whole with water, without crushing them. It is recommended to take the capsules with food, that is, during meals or immediately before or after them.Do not open or break the capsule (see section5, “Conservation of Ofev”).

To make it easier to swallow the capsules, you can take themwith a small amount (one teaspoon) of a soft, cold or room-temperature food, such as apple sauce or chocolate pudding. Swallow the capsules immediately and do not crush them to ensure they remain intact.

Adults

The recommended dose is one capsule of 100mg twice a day (a total of 200mg per day).

Do not take more than the recommended dose of two Ofev 100mg capsules per day.

If you do not tolerate the recommended dose of two Ofev 100mg capsules per day (see possible side effects in section4), your doctor may recommend that you stop taking this medication. Do not reduce the dose or interrupt treatment on your own without consulting your doctor first.

Use in children and adolescents

The recommended dose depends on the patient's weight.

Inform your doctor if, at any time during treatment, the patient's weight is less than 13.5kg.

Inform your doctor if you have liver problems.

Your doctor will determine the correct dose. Your doctor may adjust the dose during the course of treatment.

If you do not tolerate the recommended daily dose of Ofev capsules (see possible side effects in section4), your doctor may reduce the daily dose of Ofev.

Do not reduce the dose or interrupt treatment on your own without consulting your doctor first.

Dosage based on weight for Ofev capsules in children and adolescents:

If you take more Ofev than you should

Contact your doctor or pharmacist immediately.

If you forgot to take Ofev

Do not take two capsules together if you forgot to take your previous dose. You should take your next Ofev dose according to the established schedule at the next recommended hour and as indicated by your doctor or pharmacist.

If you interrupt treatment with Ofev

Do not stop taking Ofev without consulting your doctor first. It is essential to take this medication every day while your doctor prescribes it.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

You should pay special attention if you experience the following side effects during treatment with Ofev:

Diarrea(very common, may affect more than 1 in 10 people):

Diarhea can cause dehydration: a loss of important body fluids and salts (electrolytes, such as sodium or potassium). If you experience the first symptoms of diarrhea, drink plenty of liquid and consult your doctor immediately. Start an appropriate antidiarrheal treatment as soon as possible, for example, by taking loperamide.

The following side effects have also been observed during treatment with this medicine.

Consult your doctor if you experience any type of side effect.

Idiopathic Pulmonary Fibrosis (IPF)

Very common side effects (may affect more than 1 in 10 people)

• Nausea (gag reflex)
• Abdominal pain
• Abnormal liver test results

Common side effects (may affect up to 1 in 10 people)

• Vomiting
• Loss of appetite
• Weight loss
• Bleeding
• Rash
• Headache

Uncommon side effects (may affect up to 1 in 100 people)

• Pancreatitis
• Colitis
• Severe liver problems
• Low platelet count (thrombocytopenia)
• High blood pressure
• Ictericia, i.e., yellowing of the skin and eyes due to high bilirubin levels
• Itching
• Myocardial infarction
• Hair loss (alopecia)
• Increased protein in the urine (proteinuria)

Frequency not known (cannot be estimated from available data)

• Renal failure
• Increased and weakened wall of a blood vessel or rupture of the wall of a blood vessel (aneurysms and arterial dissections)
• Cerebral disorder with symptoms such as headache, changes in vision, confusion, convulsions, or other neurological changes such as weakness in an arm or leg, with or without high blood pressure (posterior reversible encephalopathy syndrome)

Other chronic fibrosing interstitial lung diseases (cEIP) with a progressive phenotype

Very common side effects (may affect more than 1 in 10 people)

• Nausea (gag reflex)
• Vomiting
• Loss of appetite
• Abdominal pain
• Abnormal liver test results

Common side effects (may affect up to 1 in 10 people)

• Weight loss
• High blood pressure
• Bleeding
• Severe liver problems
• Rash
• Headache

Uncommon side effects (may affect up to 1 in 100 people)

• Pancreatitis
• Colitis
• Low platelet count (thrombocytopenia)
• Ictericia, i.e., yellowing of the skin and eyes due to high bilirubin levels
• Itching

Frequency not known (cannot be estimated from available data)

• Myocardial infarction
• Pancreatitis
• Ictericia, i.e., yellowing of the skin and eyes due to high bilirubin levels
• Increased and weakened wall of a blood vessel or rupture of the wall of a blood vessel (aneurysms and arterial dissections)
• Hair loss (alopecia)
• Increased protein in the urine (proteinuria)
• Cerebral disorder with symptoms such as headache, changes in vision, confusion, convulsions, or other neurological changes such as weakness in an arm or leg, with or without high blood pressure (posterior reversible encephalopathy syndrome)

Interstitial lung diseases (cEIP) associated with systemic sclerosis (cEIP-SSc)

Very common side effects (may affect more than 1 in 10 people)

• Nausea (gag reflex)
• Vomiting
• Abdominal pain
• Abnormal liver test results

Common side effects (may affect up to 1 in 10 people)

• Bleeding
• High blood pressure
• Loss of appetite
• Weight loss
• Headache

Uncommon side effects (may affect up to 1 in 100 people)

• Colitis
• Severe liver problems
• Renal failure
• Low platelet count (thrombocytopenia)
• Rash
• Itching

Frequency not known (cannot be estimated from available data)

• Myocardial infarction
• Pancreatitis
• Ictericia, i.e., yellowing of the skin and eyes due to high bilirubin levels
• Increased and weakened wall of a blood vessel or rupture of the wall of a blood vessel (aneurysms and arterial dissections)
• Hair loss (alopecia)
• Increased protein in the urine (proteinuria)
• Cerebral disorder with symptoms such as headache, changes in vision, confusion, convulsions, or other neurological changes such as weakness in an arm or leg, with or without high blood pressure (posterior reversible encephalopathy syndrome)

Interstitial lung diseases (cEIP) in children and adolescents

The side effects in children and adolescents were similar to the side effects in adult patients.

Inform your doctor if you experience any type of side effect.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister pack. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Store in the original packaging to protect it from moisture.

Do not use this medication if you observe that the blister pack containing the capsules is open or that a capsule is broken.

If you come into contact with the contents of the capsule, wash your hands immediately with plenty of water (see section3, “How to take Ofev”).

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Ofev

-The active ingredient is nintedanib. Each capsule contains 100mg of nintedanib (as esilate).

-The other components are:

Caplet content:medium-chain triglycerides, hard fat, soy lecithin(E322) (see section 2, “Do not take Ofev”)

Outer capsule coating:gelatin, glycerol (85%), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172)

Appearance of the product and contents of the package

Ofev 100mg capsules are soft gelatin oval-shaped, opaque, and yellowish-orange(approximately 16×6mm), marked on one side with the Boehringer Ingelheim logo and the number“100”.

There are two package sizes of Ofev 100mg capsules:

-30×1capsules in pre-cut, unit-dose blisters of aluminum/aluminum

-60×1capsules in pre-cut, unit-dose blisters of aluminum/aluminum

Only some package sizes may be marketed.

Marketing Authorization Holder

Boehringer Ingelheim International GmbH

Binger Strasse173

55216Ingelheim am Rhein

Germany

Responsible for manufacturing

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse173

55216Ingelheim am Rhein

Germany

Boehringer Ingelheim France

100-104 Avenue de France

75013 Paris

France

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

The detailed information on this medicine is available on the website of the European Medicines Agency:https://www.ema.europa.eu.